Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

Prostate Cancer Clinical Trial

Official title:

Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310192
• Other study ID #: RA-2004-040
• Secondary ID: PC04130
• Status: Completed
• Phase: Phase 1
• Start date: June 2004
• Est. completion date: July 2008

Study information

• Verified date: July 2022
• Source: Queen's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH) positron emission tomography (PET) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. The proposed technique works by measuring the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. The project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion Criteria:

• Weight > 300 lb

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Fluourine-18 Fluoromethylcholine PET/CT Imaging
Single-dose Study

Locations

Country	Name	City	State
United States	Tripler Army Medical Center	Tripler AMC	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
Queen's Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (4)

DeGrado TR, Kwee SA, Coel MN, Coleman RE. The impact of urinary excretion of (18)F-labeled choline analogs. J Nucl Med. 2007 Jul;48(7):1225. — View Citation

Kwee SA, Coel MN, Lim J, Ko JP. Prostate cancer localization with 18fluorine fluorocholine positron emission tomography. J Urol. 2005 Jan;173(1):252-5. — View Citation

Kwee SA, DeGrado TR, Talbot JN, Gutman F, Coel MN. Cancer imaging with fluorine-18-labeled choline derivatives. Semin Nucl Med. 2007 Nov;37(6):420-8. Review. — View Citation

Kwee SA, Thibault GP, Stack RS, Coel MN, Furusato B, Sesterhenn IA. Use of step-section histopathology to evaluate 18F-fluorocholine PET sextant localization of prostate cancer. Mol Imaging. 2008 Jan-Feb;7(1):12-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis		Immediate - no longitudinal data collected